Common questions about periodontal (gum) disease and ARESTIN®

Gum disease is a bacterial infection that can lead to damage to the gums, tissue, and bone around your teeth. The destruction of tissue and bone causes pockets to form around teeth. ARESTIN® with scaling and root planing can help address some of the symptoms of gum disease.

For periodontal (gum) disease treatment, dental professionals use a common mechanical procedure known as SRP. Scaling removes bacterial plaque, tartar, and stains from the surface of teeth and their roots. Planing smoothes the rough areas on the roots of teeth to promote healing. This procedure is also known as a deep cleaning.

Bacteria are the cause of gum disease. And antibiotics kill bacteria. Scaling and root planing (SRP) removes a great deal of bacteria that cause periodontal infection. But this procedure can’t reach all bacteria that hide in the bottom of pockets. That’s why your dentist may decide to add a locally administered antibiotic (LAA) such as ARESTIN®.

Infections in your gums can enter your bloodstream and have an adverse impact on your overall health. Evidence suggests advanced gum disease may be linked to serious health conditions such as heart disease, stroke, and diabetes.

There are many factors that may put someone at risk for gum disease. Talk to your dentist about your specific risk factors. One important factor that can lead to gum disease is poor oral hygiene. Brushing twice a day, flossing daily, and regular dental cleanings help prevent plaque buildup. This helps guard against gum disease.

Good brushing and flossing habits are vital to strong oral health. Practice good oral hygiene by brushing, flossing, and rinsing daily. Use
an American Dental Association (ADA) Accepted antimicrobial rinse. Use as directed. However, regular dental checkups are critical to the prevention of more serious oral infections.

ARESTIN® is a prescription antibiotic approved by the Food and Drug Administration (FDA). It is used with scaling and root planing (SRP) procedures and is placed by your dentist for the treatment of periodontal pockets.

Although the microspheres are not visible, if you could see them, they would look like tiny, round, dry powder beads of different sizes, which contain the antibiotic minocycline. This technology allows extended release of the antibiotic so that it works to kill bacteria that cause periodontal (gum) disease over time.

ARESTIN® is used with scaling and root planing (SRP) procedures and is placed by a dentist directly into the infected site. Treating periodontal (gum) disease with ARESTIN® with SRP may help you manage adult periodontitis more effectively than SRP alone.

The use of a locally administered antibiotic (LAA) is not a new concept. For years, dental professionals have used antibiotics in conjunction with scaling and root planing (SRP) procedures. ARESTIN® was approved by the Food and Drug Administration in 2001. ARESTIN® is the only LAA containing minocycline. It has been proven to be more effective than SRP alone.

ARESTIN® uses microsphere technology to deliver the minocycline antibiotic right where it is needed to kill bacteria that cause periodontal (gum) disease. The active agent, minocycline, is placed painlessly under the gums, directly in the infected site.

Many patients with periodontal (gum) disease can benefit from ARESTIN®.

However, ARESTIN® should not be used in any patient who has a known allergy or sensitivity to minocycline or tetracycline. In addition, ARESTIN® should not be used in children or in women who are pregnant or nursing a baby.

The use of ARESTIN® in an acutely abscessed periodontal pocket has not been studied and is not recommended.

ARESTIN® has not been clinically tested in immunocompromised patients (such as those immunocompromised by diabetes, chemotherapy, radiation therapy, or infection with HIV). If superinfection is suspected, appropriate measures should be taken.

ARESTIN® was studied in 748 adult patients with periodontal (gum) disease in 2 multicenter clinical research trials in the United States. These clinical research studies allowed for the collection of data establishing the safety and effectiveness of ARESTIN®. ARESTIN® is placed directly into the infected site to kill bacteria that cause the disease.

ARESTIN® with scaling and root planing (SRP) can significantly reduce the depth of the infected pockets that can form around teeth and help prevent disease progression. The combination of ARESTIN® with SRP is more effective at fighting gum disease than SRP alone.

Patients treated with ARESTIN® may experience side effects. The most frequent non-dental adverse experiences reported in clinical research trials were headache, infection, flu syndrome, and pain. The most frequent dental treatment-emergent adverse experiences were inflammation of the gums, tooth disorder, tooth caries (cavities), and dental pain.

Interactions with ARESTIN® and other drugs have not been studied. We recommend that you consult your physician about any health concerns or conditions you may have. Your physician will be most familiar with you and your personal medical history.

No. ARESTIN® should not be used in any patient who has a known allergy or sensitivity to minocycline or tetracycline. To follow good medical practice you should talk with your dentist about any health concerns or conditions you may have, as your dentist is familiar with you and your personal medical history.

An interaction with ARESTIN® and penicillin has not been studied. We recommend that you consult your physician and dental professional about any health concerns you may have. They will be the most familiar with you and your personal medical history.

No. ARESTIN® contains minocycline, an antibiotic of the tetracycline class, and therefore should not be used in children and in pregnant or nursing women. The use of drugs of the tetracycline class may cause permanent discoloration of developing teeth.

The use of ARESTIN® in pregnant or nursing women has not been studied. We recommend you consult your physician and dental professional about any health concerns or conditions you may have, as they are familiar with you and your personal medical history.

To achieve the best results, follow the instructions given by your dental professional. You'll also find these important guidelines useful after treatment with ARESTIN®:

Avoid touching areas of your gums that your dental professional has treated for 1 week

Wait 10 days before using floss, toothpicks, or other devices designed to clean between teeth in the areas that were treated with ARESTIN®

Avoid eating hard, crunchy, or sticky foods such as carrots, taffy, and gum for 1 week after treatment

Be sure to return for your follow-up appointments, since periodontal (gum) disease can recur and gums need to be checked regularly

You should notify your dental professional promptly if pain, swelling, or other problems occur. To get the best results from your ARESTIN® treatment follow the recommendations above. Your dental professional may also have additional recommendations for getting good results.

The cost of ARESTIN® varies depending on how much treatment you need. After your dental professional has evaluated your oral health and discussed treatment options, he or she can provide you with an estimate of the cost. Keep in mind that treating periodontal (gum) disease today is less costly and better for your health than waiting to treat symptoms at a more advanced stage.

Many insurance plans provide some assistance with costs. You should talk with your dentist and his or her office staff about payment options and obtaining reimbursement for treatment.

INDICATION
ARESTIN® is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN® may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.

IMPORTANT SAFETY INFORMATION
ARESTIN® should not be used in any patient who has a known sensitivity to minocycline or tetracyclines. The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of the teeth, and therefore should not be used in children or in pregnant or nursing women. Hypersensitivity reactions that included, but were not limited to, anaphylaxis, angioneurotic edema, urticaria, rash, swelling of the face, and pruritus have been reported with the use of ARESTIN®. In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome and pain.